C&Q Engineer

C&Q Engineer

Location: Little Island, Cork

Duration: 12 months (opportunity for a contract extension)

Hours: Full-time, 39 hours per week

Pay rate range: Competitive hourly rate (PAYE, Umbrella and Ltd options available)

Imagine your next project as C&Q Engineer. As part of the Technical Compliance Team, this contract position is responsible for all activities required to support project commissioning and qualification within the Johnson & Johnson Little Island, Innovative Medicine site.

The role of the C&Q Engineer and associated activities include (but not limited to), the preparation and execution of commissioning and qualification protocols (where applicable) for site systems / equipment such as Reactors, Centrifuges, Dryers, Powder Handling Units, Skids, Vessels, Tanks, Pumps, Laminar Airflow Booths, autoclaves and isolators and clean / gray utility systems (such as purified water, water for injection clean steam, HVAC, Process Gases, Steam and Condensate systems etc.).

roles and responsibilities

• Provide input into all aspects of C&Q i.e. from design through to commissioning and qualification completion.

• Support and participate in the design of systems and equipment to ensure they comply with cGMP requirements. 

• Prepare C&Q protocols as required (e.g. URS’s / SRS’s, Plans, Impact Assessments, DQ, IQ, OQ, PQ protocols and Reports).

• Review and approve documents prepared by contractor organisations (e.g. vendor SAT’s, FAT’s, commissioning protocols, project change controls/notifications). 

• Execute C&Q protocols as required.

• Compile relevant documentation from vendors, contractors, and other departments for inclusion in protocols / reports.

• Complete activities / deliverables in accordance with each project’s site change control required deliverables (from a C&Q perspective).

• Track and support the resolution of Commissioning punch list items and Qualification deviations during the C&Q execution phase.

• Prioritize C&Q activities in line with site and project schedules.

• Co-ordinate C&Q activities with project engineering, construction and site operations activities.

• Co-ordinate C&Q activities with contractors and vendors as required.

• Co-ordinate C&Q document reviews and approvals.

• C&Q System / Equipment / Components as per site procedures.

• Strong collaboration with Quality Department.

how to succeed

• Minimum 5+ years’ experience in the Pharmaceutical (API) Industry.

• Experience of commissioning and qualifying some of the following systems: 

  • Reactors, Centrifuges, Dryers, Powder Handling Units, Skids, Vessels, Tanks, Pumps, Laminar Airflow Booths, autoclaves and isolators and clean / gray utility systems (such as purified water, water for injection clean steam, HVAC, Process Gases, Steam and Condensate systems etc.).

• Experience preparing and executing commissioning and qualification protocols and reports. 

• Knowledge and experience of Project Delivery Processes (PDP).

• Knowledge and experience of current Good Engineering Practices (GEP).

Following would be an advantage,

• Experience with use of ABB Industrial IT control systems.

• Experience of Pharmaceutical facility local and controlling instrumentation.

• Third level degree and relevant experience.

Required Knowledge, Skills and Abilities:

• Knowledge of GMP guidelines and regulation Q7A, etc.

• Experience in cGMP regulated environment.

• Extensive experience of commissioning and qualification of production systems, utilities and facilities and change management.

• Effectively partners and delivers results in a matrix environment; works collaboratively across site functions.

• Strong communication and interpersonal skills, ability to influence/impact.

• Excellent knowledge of English, both verbally and written.

• High degree of competency and experience of Microsoft Office suite, Word, Excel, Outlook etc.

Desirable:

• Experience of working within a Technical Compliance / Project team in a multinational corporate environment.

• Experience of ASTM 2500 and/or Risk Based Qualification approach.

Key Competencies Required

• Ability to operate as part of a team is critical. 

• Excellent interpersonal skills.

• Customer focus.

• Innovative.

• Technical aptitude. 

• Excellent communication skills both written and verbal. 

• Attention to detail.

• Good problem-solving skills. 

• Results and performance driven. 

• Adaptable and flexible.

benefits

This role offers a very competitive hourly rate. This contract will run for 12 months and has a strong chance of extension. 

you are welcome here

Johnson & Johnson Innovative Medicine is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

Janssen Ireland: https://www.janssen.com/ireland/

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella options are available. 

questions

If you would like some additional information about the role please contact: sara.marsalo@randstadsourceright.co.uk (please note that we do not accept applications via email, please apply through the portal).

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.